The Effects of Gabapentin Premedication on Neurosurgery

October 13, 2017 updated by: Wei Zhang, Capital Medical University

The Effects of Gabapentin Premedication on Postoperative Pain,Nausea,Vomiting and Sedation in Patients Undergoing Neurosurgery

The study is to observe the effects of gabapentin premedication on postoperative pain,vomiting and nausea in patients undergoing neurosurgery. 100 neurosurgical patients are randomized into groups gabapentin(GG) or placebo(GP). Patients are given gabapentin or placebo orally the night before operation day and 2hours before surgery,respectively.The investigators hypothesized that lower incidence of postoperative pain,vomiting and nausea be observed in GG than GP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a random, double-blind study. In GG, patients are given gabapentin 600mg orally at the night and 2hours before surgery, respectively. In PG, vitamine pills are given instead.Total intravenous anesthesia is applied for all patients. 1hour, 2hours,1day, 2days, 3months and 6months after surgery, patients are evaluated for pain (VAS) and incidence of PONV. In addition,Glasgow Score, Ramsay Score and other gabapentin-related effects, such as somnolence,dizzy or dry mouth are also observed.The incidence of persistent pain and neuropathic pain was assessed at the 3-mo and 6-mo postoperative evaluation.

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-65 years old, ASA physical status I or II, BMI<30
  • Scheduled for elective craniotomy
  • Cooperative and given informed consent in person

Exclusion Criteria:

  • History of mental or psychiatric disorders
  • Pregnant or lactating female
  • History of systemic malignant tumor or diabetes
  • Previously treated with this protocol or participated in another experimental study within previous 30 days
  • Suspected history of allergic reaction or intolerance to gabapentin or other anesthetic agents in this study
  • History of alcohol abuse and/or drug abuse within previous one year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: vitamin capsules
vitamin capsules orally at the night before operation and 2 hours before surgery,respectively
Drug: vitamin capsules
vitamin B
Experimental: gabapentin
gabapentin 600mg orally at the night before operation and 2 hours before surgery,respectively
Drug: gabapentin
gabapentin capsules 0.3g

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Premedication gabapentin can decrease pain in early postoperative period
Time Frame: 24 hour after extubation
postoperative pain scores(Visual Analogue Scale)
24 hour after extubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Premedication gabapentin can limit the development of persistent pain and neuropathic pain.
Time Frame: 3-mos and 6-mos after surgery
postoperative pain scores(Visual Analogue Scale) and the Leeds assessment of neuropathic symptoms and signs (LANSS) Pain Scale
3-mos and 6-mos after surgery
Preoperative gabapentin can lead to a decrease incidence of PONV
Time Frame: 1 hour,2 hours,1day,2 days after surgery
Incidence of PONV
1 hour,2 hours,1day,2 days after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The gabapentin-related effects on neurosurgical patients
Time Frame: 1 hour,2 hours,1day,2 days after surgery
Glasgow Score, Ramsay Score , somnolence,dizzy or dry mouth
1 hour,2 hours,1day,2 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Investigators

  • Study Chair: Ru Quan Han, chief, Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

April 16, 2014

First Submitted That Met QC Criteria

December 2, 2014

First Posted (Estimate)

December 3, 2014

Study Record Updates

Last Update Posted (Actual)

October 16, 2017

Last Update Submitted That Met QC Criteria

October 13, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ky2013-008-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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